Reference no: EM133430526

Assignment:

Trace Matrix

Choose a specific medical device that is on the market. For the particular device chosen provide the following information:

1. List at least 4 design inputs

2. List at least 4 design outputs

3. Provide the intended use

4. Provide the indications for use

For each design input list a deliverable (i.e., plan, protocol, report, etc.). For each design output list a deliverable (i.e., report, labeling, risk assessment document, etc.). Provide a trace matrix for the device you have chosen based on the items listed above. The trace matrix should be in table format using MS Word.

You should be able to provide the first two items based on the type of medical device chosen. For example, you have chosen a heart valve as your medical device. The heart valve has certain dimensions and is made out of a polymer material.

A design input requirement is the overall length of the heart value must be 2 inches long. Another design input requirement is that the polymer material must be ¼ inch in thickness. The output for both could be drawings. You can find information on the FDA website and the manufacturers product website. You may need to make some educated guesses regarding design input.

Explain and list the References/sources used to explain.